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Sr. Supplier Quality Engineer

Lead supplier quality initiatives to ensure compliance and continuous improvement in medical device manufacturing
Morrisville, North Carolina, United States
Senior
20 hours agoBe an early applicant
Teleflex

Teleflex

A global provider of medical technologies designed to improve the health and quality of people's lives.

Sr. Supplier Quality Engineer

This position is a key liaison between Global Procurement, Site Buyers, Site Quality, and business units, ensuring high-quality materials, products, and services. It drives supplier performance through improvement initiatives, resolving complex quality issues, and building strategic supplier relationships. The role involves developing and managing supplier quality agreements, compliance, and audits. It supports supplier qualifications, component testing, and manages supplier-initiated changes, using quality data for decision-making and continuous improvement. The Senior Supplier Quality professional also acts as a quality representative during acquisitions, collaborating with teams in Quality Assurance, Regulatory Affairs, Supply Chain, Design, and Manufacturing. Additionally, it involves mentoring team members and representing supplier quality in cross-functional projects to meet company and regulatory goals.

• Coordinate with Global Procurement, Site Buyers, and Site Quality to provide the appropriate supplier quality support for the purchase of Commodities, PFG's, and Critical Services • Perform supplier compliance and qualification functions and activities for prospective new commodity, PFG, and critical service suppliers • Work with Global Procurement, Strategic Sourcing, Site Buyers, and Site Quality on the development of key and critical suppliers to improve supplier's performance, quality, cost, responsiveness, and technology • Perform supplier development activities with suppliers of defective materials, including developing and executing supplier quality plans, conducting "for-cause" audits, SCAR follow-up, coordinating business reviews, and implementing six-sigma and continuous improvement methods and techniques

• Implement quality improvements related to suppliers of materials, products, or critical services in development or manufacturing • Resolve ineffective supplier corrective action plans with suppliers • Coordinate component and product quality testing • Coordinate supplier-initiated change requests • Analyze and identify trends from quality data and develop proactive measures with the supplier in support of continuous improvement • Lead supplier-related activities in support of business objectives • Assist the business units with the acquisition of new companies and the integration of their suppliers into the Teleflex quality system • Serve on project teams in the area of problem-solving methodologies • Provide other departmental support requested by the immediate supervisor • Adhere to and ensure compliance to the Teleflex code of conduct, all company policies, rules, procedures, and housekeeping standards

• Four-year college degree with a scientific/technical discipline preferred • 5-10 years of experience working within an FDA regulated industry, Medical Device preferred • Advanced problem solving and root cause analysis • Advanced knowledge of 21 CFR 820, ISO 13485, and ISO 9001 (with emphasis on purchasing controls) • Knowledge of statistical techniques • Minimum 5 years of auditing experience (3rd party certification preferred) • Engineering degree or 3rd party engineering certification preferred (ASQ CQE)

• Commitment to Goals –A strong commitment to achieving goals is essential for personal and team success. It requires taking ownership of tasks, staying focused on priorities, and consistently delivering high-quality work. Being proactive, managing time effectively, and seeking support when needed are critical to meeting deadlines and overcoming challenges. By aligning personal efforts with team and organizational objectives, individual contributors play a vital role in driving results and advancing shared goals.

• Continuous Improvement - Continuous improvement means actively seeking ways to enhance your work, skills, and contributions. It's critical to stay curious, embrace feedback, and look for opportunities to streamline processes or solve problems more effectively. Individual contributors should take initiative to learn from experiences, adapt to change, and apply new knowledge to drive better outcomes. By consistently striving to improve, they add value to their team and support the organization's growth and success.

• Culture and Values – Living our culture and values is essential to fostering a positive, collaborative work environment. Individual contributors demonstrate this by treating others with respect, acting with integrity, and contributing to an inclusive and supportive team culture. It's critical to hold oneself accountable, align actions with shared values, and support the broader mission of the organization. By consistently modeling these behaviors, individual contributors help strengthen the workplace culture and positively influence those around them.

• Experience with manufacturing • Experience with Visio, Access, Microsoft Word, Excel, PowerPoint, SharePoint and statistical applications • Excellent verbal communication (English language) • Excellent technical writing skills (English language) • Excellent presentation skills • Team facilitation skills • Experience with Minitab preferred

TRAVEL REQUIRED: 30 % WORKING ENVIRONMENT: Office/Professional Plant/Manufacturing Remote/Field Laboratory

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Sr. Supplier Quality Engineer
Morrisville, North Carolina, United States
Engineering
About Teleflex
A global provider of medical technologies designed to improve the health and quality of people's lives.